Skin Tension in the Aetiology of Dupuytren’s Disease; a Prospective Trial

Citron, N.; Hearnden, A.

doi:10.1016/s0266-7681(03)00221-3

Cited by 60 publications

(44 citation statements)

References 9 publications

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“…69 The two non-randomised studies assessing collagenase versus surgery were both conducted in the USA. 71,72 Of the surgery non-randomised studies, one was conducted in several countries, 73 one in the UK, 74 one in Brazil, 57 one in the USA 75 and one in Australia. 76 Nine of the collagenase case series were conducted in the USA 48,77,81,83,[85][86][87][88][89] two in Australia, 78,79 one in the UK, 91 one in Spain, 84 one in several countries, 90 and the remaining one did not report this information.…”

Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

“…57,[73][74][75][76] The 15 collagenase case series enrolled a total of 3154 participants and analysed 3139 of them. However, some collagenase case series relied on the same patient cohorts 81,87,90 and we could not establish with certainty whether there was duplication of data because of multiple publications.…”

Section: -69mentioning

confidence: 99%

“…The two non-randomised studies comparing collagenase with surgery 71,72 and the five non-randomised studies comparing various surgical procedures 44,57,[73][74][75][76] were published in full. Three studies collected data prospectively 72,74,75 and three retrospectively.…”

mentioning

confidence: 99%

“…Three studies collected data prospectively 72,74,75 and three retrospectively. 71,73,76 One study did not report this information.…”

mentioning

confidence: 99%

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Collagenase clostridium histolyticum for the treatment of Dupuytren’s contracture: systematic review and economic evaluation

Brazzelli

Cruickshank

Tassie

et al. 2015

Health Technol Assess

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BackgroundDupuytren’s disease is a slowly progressive condition of the hand, characterised by the formation of nodules in the palm that gradually develop into fibrotic cords. Contracture of the cords produces deformities of the fingers. Surgery is recommended for moderate and severe contractures, but complications and/or recurrences are frequent. Collagenase clostridium histolyticum (CCH) has been developed as a minimally invasive alternative to surgery for some patients.ObjectivesTo assess the clinical effectiveness and cost-effectiveness of collagenase as an alternative to surgery for adults with Dupuytren’s contracture with a palpable cord.Data sourcesWe searched all major electronic databases from 1990 to February 2014.Review methodsRandomised controlled trials (RCTs), non-randomised comparative studies and observational studies involving collagenase and/or surgical interventions were considered. Two reviewers independently extracted data and assessed risk of bias of included studies. A de novo Markov model was developed to assess cost-effectiveness of collagenase, percutaneous needle fasciotomy (PNF) and limited fasciectomy (LF). Results were reported as incremental cost per quality-adjusted life-year (QALY) gained. Deterministic and probabilistic sensitivity analyses were undertaken to investigate model and parameter uncertainty.ResultsFive RCTs comparing collagenase with placebo (493 participants), three RCTs comparing surgical techniques (334 participants), two non-randomised studies comparing collagenase and surgery (105 participants), five non-randomised comparative studies assessing various surgical procedures (3571 participants) and 15 collagenase case series (3154 participants) were included. Meta-analyses of RCTs assessing CCH versus placebo were performed. Joints randomised to collagenase were more likely to achieve clinical success. Collagenase-treated participants experienced significant reduction in contracture and an increased range of motion compared with placebo-treated participants. Participants treated with collagenase also experienced significantly more adverse events, most of which were mild or moderate. Four serious adverse events were observed in the collagenase group: two tendon ruptures, one pulley rupture and one complex regional pain syndrome. Two tendon ruptures were also reported in two collagenase case series. Non-randomised studies comparing collagenase with surgery produced variable results and were at high risk of bias. Serious adverse events across surgery studies were low. Recurrence rates ranged from 0% (at 90 days) to 100% (at 8 years) for collagenase and from 0% (at 2.7 years for fasciectomy) to 85% (at 5 years for PNF) for surgery. The results of the de novo economic analysis show that PNF was the cheapest treatment option, whereas LF generated the greatest QALY gains. Collagenase was more costly and generated fewer QALYs compared with LF. LF was £1199 more costly and generated an additional 0.11 QALYs in comparison with PNF. The incremental cost-effectiveness ratio was £10,871 per QALY gained. Two subgroup analyses were conducted for a population of patients with moderate and severe disease and up to two joints affected. In both subgroup analyses, collagenase remained dominated.LimitationsThe main limitation of the review was the lack of head-to-head RCTs comparing collagenase with surgery and the limited evidence base for estimating the effects of specific surgical procedures (fasciectomy and PNF). Substantial differences across studies further limited the comparability of available evidence. The economic model was derived from a naive indirect comparison and was hindered by a lack of suitable data. In addition, there was considerable uncertainty about the appropriateness of many assumptions and parameters used in the model.ConclusionsCollagenase was significantly better than placebo. There was no evidence that collagenase was clinically better or worse than surgical treatments. LF was the most cost-effective choice to treat moderate to severe contractures, whereas collagenase was not. However, the results of the cost–utility analysis are based on a naive indirect comparison of clinical effectiveness, and a RCT is required to confirm or refute these findings.Study registrationThis study is registered as PROSPERO CRD42013006248.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Assessment Of Clinical Effectivenessmentioning

confidence: 99%

Section: -69mentioning

confidence: 99%

mentioning

confidence: 99%

“…Three studies collected data prospectively 72,74,75 and three retrospectively. 71,73,76 One study did not report this information.…”

mentioning

confidence: 99%

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Collagenase clostridium histolyticum for the treatment of Dupuytren’s contracture: systematic review and economic evaluation

Brazzelli

Cruickshank

Tassie

et al. 2015

Health Technol Assess

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“…Another prospective, pseudo-randomized study of open fasciotomy (not fasciectomy) patients found recurrence in 2 years for 7/14 treated with direct closure and in 2/13 closed with a Z-plasty [14].…”

Section: Dermofasciectomymentioning

confidence: 99%

Dupuytren's Disease: Current State of the Art

Henry

2013

Hand (New York, N,Y.)

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Background This review article critically examines the current literature for Dupuytren's disease. Methods Five procedures are considered: dermofasciectomy, limited fasciectomy, segmental aponeurectomy, needle aponeurotomy, and collagenase injection. Studies regarding the efficacy of these treatments focus primarily on the initial degree of correction, rate of recurrence, and complications. Results No one treatment has been declared superior and substantial controversy exists. Comparison between studies has been hampered by the absence of uniform definitions for clinical success and measurable disease progression. Traditional postoperative care includes formal therapy and night splinting, but recent studies have questioned the value of these adjuncts. Conclusion The extent of involvement at which the surgeon should intervene was previously well accepted by convention, but as the paradigm shifts towards less invasive procedures, treatment may be offered at an earlier stage. Future research should be structured to recognize the value-based decision making used by patients when selecting treatment.

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Surgery for Dupuytren's contracture of the fingers

Rodrigues

Becker

Ball

et al. 2015

Cochrane Database of Systematic Reviews

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Data collection and analysis A minimum of two review authors independently reviewed search results to select studies for inclusion by using pre-specified criteria, assessed risk of bias of included studies and extracted data from included studies. We grouped outcomes into the following categories: (1) hand function, (2) other patient-reported outcomes (e.g. satisfaction, pain), (3) early objective outcomes (e.g. correction of angular deformity), (4) late objective outcomes (e.g. recurrence) and (5) adverse effects. Main results We included 14 articles describing 13 studies, comprising 11 single-centre studies and two multi-centre studies. These studies involved 944 hands of 940 participants; of these, 93 participants were reported twice in separate articles describing early and late outcomes of one trial. Three papers reported the outcomes of two trials comparing different procedures. One trial compared needle fasciotomy versus fasciectomy (125 hands, 121 participants), and the other compared interposition firebreak skin grafting versus z-plasty closure of fasciectomy (79 participants). The other 11 studies reported trials of technical refinements of procedures or rehabilitation adjuncts. Of these, three investigated effects of postoperative splinting on surgical outcomes. Ten studies (11 articles) were randomised controlled trials (RCTs) of varying methodological quality; one was a controlled clinical trial. Trial design was unclear in two studies awaiting classification. All trials had high or unclear risk of at least one type of bias. High risks of performance and detection bias were particularly common. We downgraded the quality of evidence (Grades of Recommendation, Assessment, Development and Evaluation-GRADE) of outcomes to low because of concerns about risk of bias and imprecision. Outcomes measured varied between studies. Five articles assessed recurrence; two defined this as reappearance of palpable disease and two as deterioration in angular deformity; one did not explicitly define recurrence. Hand function on the Disabilities of the Arm, Shoulder and Hand (DASH) Scale (scores between 0 and 100, with higher scores indicating greater impairment) was 5 points lower after needle fasciotomy than after fasciectomy at five weeks. Patient satisfaction was better after fasciotomy at six weeks, but the magnitude of effect was not specified. Fasciectomy improved contractures more effectively in severe disease: Mean percentage reduction in total passive extension deficit at six weeks for Tubiana grades I and II was 11% lower after needle fasciotomy than after fasciectomy, whereas for grades III and IV disease, it was 29% and 32% lower. Paraesthesia (defined as subjective tingling sensation without objective evidence of altered sensation) was more common than needle fasciotomy at one week after fasciectomy (228/1000 vs 67/1000), but reporting of complications was variable. By five years, satisfaction (on a scale from 0 to 10, with higher scores showing greater satisfaction) was 2.1/10 points higher in the fasciect...

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Skin Tension in the Aetiology of Dupuytren’s Disease; a Prospective Trial

Cited by 60 publications

References 9 publications

Collagenase clostridium histolyticum for the treatment of Dupuytren’s contracture: systematic review and economic evaluation

Collagenase clostridium histolyticum for the treatment of Dupuytren’s contracture: systematic review and economic evaluation

Dupuytren's Disease: Current State of the Art

Surgery for Dupuytren's contracture of the fingers

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